Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Description of Treatment Patterns Used for cHL or sALCL |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Percentage of Participants Receiving Various Chemotherapy Regimens |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Percentage of Participants who Received Chemotherapy Regimens as per National Guidelines |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Percentage of Participants who Received Radiotherapy Including Site (Extended/Involved) and Total Dosing |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Percentage of Participants who Received Autologous Stem Cell Transplantation (AutoSCT) |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Percentage of Participants who Were Eligible for AutoSCT did not Receive it (Including Reasons) |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Percentage of Participants who Received Allogeneic Stem Cell Transplantation (AlloSCT) |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Distribution of Pre-SCT Therapy Regimens |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Distribution of First Line Treatment Patterns According to Prognostic Group |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Primary |
Distribution of Relapse/Refractory (RR) Treatment Patterns |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Overall Survival (OS) |
OS is defined as the time passed from the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed. |
From the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed (up to Month 24) |
|
| Secondary |
Disease Free Survival-1 (DSF1) |
DFS1 is defined as the time from the date of complete remission after first line of therapy till relapse or till the latest date of participant observed. |
From date of complete remission after first line of therapy up to relapse or till the latest date of participant observed (up to Month 24) |
|
| Secondary |
Freedom From Treatment Failure-1 (FFTF1) |
FFTF1 is defined as the time passed from date of initiation first therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed. |
From date of initiation first therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24) |
|
| Secondary |
Event Free Survival-1 (EFS1) |
EFS-1 is defined as the time passed from date of initiation first line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed. |
From date of initiation first therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24) |
|
| Secondary |
Percentage of Participants with Complete Remission (CR) Achieved by the end of Treatment Regimen |
CR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis less than (<) 10 millimeter (mm). |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Partial Remission (PR) Achieved by the end of Treatment Regimen |
PR based on RECIST 1.1 is defined as greater than or equal to (>=) 30 percent (%) decrease in the sum of longest diameters (SLD) of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Overall Response Achieved by the end of Treatment Regimen |
Overall response based on RECIST 1.1 is defined as the percentage of participants who have a PR or CR to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30% decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Stable Disease (SD) Achieved by the end of Treatment Regimen |
SD based on RECIST 1.1 is defined as changes in the SLD of targeted lesions ranging between reduction of <10% to an increase by <20% without the appearance of a new lesion, and irrespective of positron emission tomography (PET) results. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Progression Disease (PD) While on the Treatment |
PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Relapse (Both Early [<12 Months After the end of First Line Treatment] and Late Relapses) |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Primary Resistance |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Resistant Participants to the Second and Later Treatment Lines |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants in Whom Brentuximab Vedotin was Used |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Distribution of Treatment Patterns Containing Brentuximab Vedotin in Clinical Practice |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Disease Free Survival (DFS) After the Treatment Line Including Brentuximab Vedotin Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line |
DFS will be assessed after the treatment line including brentuximab vedotin based on the number of cycles of brentuximab vedotin performed within this Treatment Line. DFS is defined as the time from the date of complete remission till relapse or till the latest date of participant observed. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
FFTF Based on the Number of Cycles of Brentuximab Vedotin Performed Within the Treatment Line |
FFTF will be assessed based on the number of cycles of brentuximab vedotin performed within this treatment line. FFTF is defined as the time passed from date of initiation therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed. |
From initiation therapy date until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complication, death from any cause, or till observed (up to Month 24) |
|
| Secondary |
EFS Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line |
EFS will be assessed based on the number cycles of brentuximab vedotin performed within this treatment line. EFS is defined as the time passed from date of initiation therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed. |
From initiation therapy date until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24) |
|
| Secondary |
Percentage of Participants With CR Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line |
CR based on RECIST 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Overall Response Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line |
Overall response is defined as the percentage of participants who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30 % decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants With Progressive Disease Developed While on the Treatment Regimen Including Brentuximab Vedotin Achieved Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line |
PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Number of Cycles of Brentuximab Vedotin Before and After Stem Cell Transplantation (SCT) |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Distribution of Clinical Variables for cHL and sALCL at the Time of Primary Diagnosis |
Clinical variable will include stage, histological types, immunohistochemistry data (yes/no), ALK-status (negative/positive), prognostic groups, prognostic risk factors (International Prognostic Score (IPS), International Prognostic Index, Age-adjusted International Prognostic Index, International T-cell Lymphoma Project Score, Prognostic Index for peripheral T-cell lymphoma unspecified [PTCL-U] [PIT]), prognostic risk factors, and risk factors for relapse. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Distribution of Clinical Variables for cHL and sALCL at the Time of Resistance/Relapses |
Clinical variable will include stage, histological types, immunohistochemistry data (yes/no) and ALK-status (negative/positive). |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants for Whom PET and PET/Computed Tomography (CT) was Used for Primary Disease Diagnostic and Staging |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants for Whom PET and PET/CT Scan was Used for Interim Treatment Response Evaluation |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
OS Based on use of PET/CT Scan for Initial Disease Staging, Interim and Final Response Assessment During Frontline and Second Line Treatment |
OS is defined as the time passed from the date of initiation of cHL or sALCL treatment until the date of death from any cause or till the latest date of participant observed. OS will be analyzed by Cox regression. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Timepoint of Performing Interim Response Evaluation With PET/CT Scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy) |
Timepoints will include number of cycle after which the evaluation is performed and time from the start of last cycle of therapy. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of Participants for Whom PET and PET/CT Scan Were Used to Evaluate Final Treatment Response |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Timepoint of Performing Final Response Evaluation With PET/CT scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy) |
Timepoints will include number of cycle after which the evaluation is performed and time from the start of last cycle of therapy. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Time of Performing PET and PET/CT Scan After SCT |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Distribution of Imaging Patterns Used for Primary Disease Diagnostic and Staging in Different Regions of Russia |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Distribution of Imaging Patterns Used for Treatment Response Evaluation |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Distribution of Imaging Patterns Used for Disease Control of the Participants Being in Remission |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Sick Leave Sheet |
Healthcare resources will include hospitalizations and sick leave sheet. |
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Number of Hospitalizations |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Number of Days Spent on Hospital Beds |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Number of Sick Leaves |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Number of Days Spent on Sick Leaves |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
| Secondary |
Disease Free Survival-2 (DSF2) |
DFS2 is defined as the time from the date of complete remission after second line of therapy till relapse or till the latest date of participant observed. |
From date of complete remission after second line of therapy up to relapse or till the latest date of participant observed (up to Month 24) |
|
| Secondary |
Freedom From Treatment Failure-2 (FFTF2) |
FFTF2 is defined as the time passed from date of initiation second line therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed. |
From date of initiation second therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24) |
|
| Secondary |
Event Free Survival-2 (EFS2) |
EFS-2 is defined as the time passed from date of initiation second line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed. |
From date of initiation second therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24) |
|
| Secondary |
Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice |
|
From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years) |
|
